Mandatory Centralised Approval For New Drugs: Delhi High Court Affirms CDSCO’s Power To Review State-Issued FDC Licenses

The Delhi High Court affirmed the authority of the Central Drugs Standard Control Organisation (CDSCO) to review licenses for Fixed Dose Combinations (FDCs).

The Court observed that the impugned order served the interest of patient safety by ensuring that "New Drugs" were not permitted in the market without the rigorous scientific validation mandated under the New Drugs and Clinical Trials Rules, 2019.

The Bench of Justice Purushaindra Kumar Kaurav observed, "In view of the aforementioned reasons, the impugned order dated 11.04.2025 does not warrant any interference. The impugned communication merely requires the concerned State and Union Territory Drug Controllers to undertake a review of the approval process followed in respect of FDCs falling within the category of a “new drug”. It further calls upon the authorities to examine the licences granted for the manufacture, sale and distribution of such FDCs, as identified in their annexure. Concerned authorities were instructed to take appropriate action, including revocation of licenses (to manufacture, sell, and distribute) where warranted, in accordance with the provisions of the NDCT Rules, 2019, and to submit a report thereon."

Advocate Aman Saroha appeared for the Petitioners, while CGSC Nishant Gautam appeared for the Respondents.

The petitioners, being various private limited companies and firms involved in the research, manufacture, and marketing of pharmaceutical products, approached the Court to challenge an order dated 11.04.2025. This order, issued by the Central Drugs Standard Control Organisation (FDC Division), directed State and Union Territory Drug Controllers to review the approvals granted for Fixed Dose Combinations (FDCs) categorized as "New Drugs" to ensure compliance with safety standards and public welfare.

The FDC Division issued the impugned communication after it observed that certain "New Drugs" received approvals without a rigorous evaluation of their safety and efficacy. The authorities raised significant concerns regarding premature market entry, noting that such lapses directly compromised patient safety and the broader public interest.

The regulatory framework governing these approvals was found in the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules), framed under the Drugs and Cosmetics Act, 1940. According to Rule 2(1)(w)(iii), any combination of two or more previously approved drugs, when combined for the first time, fell strictly under the definition of a "new drug." This necessitated a centralised scrutiny process before any clinical testing or market authorisation could be granted.

Under Rule 3 of the NDCT Rules, the Drug Controller General of India (DCGI) was designated as the sole licensing authority. The law mandated that no clinical trial could be conducted without the express permission of the respondent and the approval of an ethics committee. This framework was further supported by the Good Clinical Practice Guidelines, which ensured that every drug was backed by pre-clinical data and periodic reporting of adverse reactions.

The Respondent submitted that a practice had emerged where State Licensing Authorities granted licenses for FDCs without adhering to these mandatory statutory requirements. This resulted in the proliferation of unapproved FDCs in the market, posing a grave risk to public health. Consequently, the impugned order directed State authorities to examine existing licenses and take appropriate action, including the revocation of licenses where scientific validation was found lacking.

The Court noted that some manufacturers had already voluntarily surrendered their licenses following the issuance of show-cause notices. It was observed that unapproved FDCs, lacking scientific validation, could lead to adverse drug reactions and other health hazards. The Court held that the Respondent-authority acted rightly in sensitising the concerned stakeholders through the impugned advisory.

"Some of the licenses were voluntarily surrendered by respective manufacturers following the show-cause notice. The unapproved FDCs compromise patient safety and may lead to adverse drug reactions and cause other health hazards due to the absence of scientific validation", it said.

Ultimately, the petitioners failed to satisfy the Court on any valid ground to set aside the advisory.

Since no valid permission was granted by the respondent for the sale of the drugs in question, the Court found no justification to interfere with the order.

Therefore, the petitions were dismissed, and all pending applications were disposed of accordingly.

Cause Title: Maxford Healthcare & Ors. v. Union of India & Ors. and other connected matters. [Neutral Citation: 2026 DHC 3690]

Appearances:

Petitioners: Advocate Aman Saroha, Advocate Kushi Sharma, Advocate Gourav Garg, Advocate Sachin.

Respondents: Central Government Standing Counsel Nishant Gautam, Advocate Kavya Shukla, Advocate Vineet Negi, Advocate Vibhav V. Nath, Advocate Theresa.

Click here to read/download the Judgment